NCT04584736已完成3 期
To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 283 人开始时间: 2019年6月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 283
- 试验地点
- 1
- 主要终点
- % change in LDL-C level from baseline at Week 8
研究概览
简要总结
To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia.
详细描述
A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary hypercholesterolemia
排除标准
- •The subject not meet the specified LDL-C level
研究组 & 干预措施
Livalo 2mg, Ezetrol 10mg
Experimental
Pitavastatin 2mg, Ezetimibe 10mg
干预措施: Livalo, Ezetrol (Drug)
Livalo 2mg
Active Comparator
Pitavastatin 2mg
干预措施: Livalo, Ezetrol (Drug)
Livalo 4mg, Ezetrol 10mg
Experimental
Pitavastatin 4mg, Ezetimibe 10mg
干预措施: Livalo, Ezetrol (Drug)
Livalo 4mg
Active Comparator
Pitavastatin 4mg
干预措施: Livalo, Ezetrol (Drug)
结局指标
主要结局
% change in LDL-C level from baseline at Week 8
时间窗: Week 8
change in LDL-C level
次要结局
- Change in LDL-C level from baseline at Week 4 and Week 8(Week 4 and Week 8)
研究者
研究点 (1)
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